(79 days)
Not Found
No
The summary describes a proton beam therapy system and an X-ray limiting accessory. There is no mention of AI or ML in the intended use, device description, or performance studies. The control of the motorized leaves is described as being done by "imaging software," which does not inherently imply AI/ML.
Yes
The device is described as producing and delivering a proton beam for the treatment of localized tumors and other conditions, which clearly indicates a therapeutic purpose.
No
The device is described as a proton beam irradiation system for therapeutic treatment of localized tumors, not for diagnosing conditions. The X-ray Limiting Accessory is used for patient positioning during treatment, not for diagnostic imaging.
No
The device description clearly states it is a "proton beam irradiation system" composed of "two main components: (1) a beam delivery system" and "(2) equipment necessary to generate the proton beam". It also describes a "X-ray Beam Limiting accessory" with "4 motorized leaves". These are all physical hardware components, not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the treatment of patients with localized tumors and other conditions using a proton beam. This is a therapeutic application, not a diagnostic one.
- Device Description: The device is described as a proton beam irradiation system designed to deliver a therapeutic proton beam. The X-ray Limiting Accessory is for limiting patient X-ray exposure during positioning for treatment, not for diagnosing a condition.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze biological samples (blood, tissue, etc.) or to provide information for the diagnosis of a disease or condition.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device operates in vivo (within the body) for therapeutic purposes.
N/A
Intended Use / Indications for Use
The PROBEAT-V with X-ray Limiting Accessory is a medical devices designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation.
Product codes (comma separated list FDA assigned to the subject device)
LHN
Device Description
The PROBEAT-V with X-ray Limiting Accessory is a proton beam irradiation system, which provides a therapeutic proton beam for clinical treatment. It is designed to deliver a proton beam with the prescribed dose, dose distribution and directed to the prescribed patient treatment site. The equipment to perform the above work is composed of two main components: (1) a beam delivery system whose primary responsibility is to ensure that the desired prescription parameters are properly delivered and (2) equipment necessary to generate the proton beam and direct it to the beam delivery system for patient treatment.
The X-ray Beam Limiting accessory for use in conjunction with the cleared PROBEAT-V system is designed to limit the patient's X-ray exposure during for patient positioning with the Cone Beam CT (CBCT). The device has 4 motorized leaves which are controlled by the PROBEAT-V imaging software to position the leaves in order to limit the patient's radiation exposure during patient positioning.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Cone Beam CT (CBCT)
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Testing was performed to evaluate that the integration of the X-ray Beam Limiting Device with the previously cleared PROBEAT-V does not impact the performance of the system. This testing evaluated slice pitch accuracy, spatial accuracy, spatial resolution, and isocenter accuracy as well as testing with the proton beam therapy positioning system. Electrical safety was evaluated and electromagnetic compatibility testing was performed with the integrated system. In all cases, the device performed as intended and met all pre-specified success criteria.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 892.5050 Medical charged-particle radiation therapy system.
(a)
Identification. A medical charged-particle radiation therapy system is a device that produces by acceleration high energy charged particles (e.g., electrons and protons) intended for use in radiation therapy. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.(b)
Classification. Class II. When intended for use as a quality control system, the film dosimetry system (film scanning system) included as an accessory to the device described in paragraph (a) of this section, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized design featuring three human profiles that are connected to each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 13, 2016
Hitachi, Ltd. % Mr. Jonathan Kahan Regulatory Counsel Hogan Lovells US LLP 555 13th Street NW WASHINGTON DC 20016
Re: K161163
Trade/Device Name: PROBEAT-V Proton Beam Therapy System with X-ray Limiting Accessory Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: LHN Dated: April 25, 2016 Received: April 25, 2016
Dear Mr. Kahan:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Michael D'Hara
For
Robert Ochs. Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known)
Device Name
PROBEAT-V Proton Beam Therapy System with X-ray Limiting Accessory
Indications for Use (Describe)
The PROBEAT-V with X-ray Limiting Accessory is a medical devices designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) | □ Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) SUMMARY
PROBEAT-V Proton Beam Therapy System with X-ray Limiting Accessory
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
Hitachi, Ltd. 2-16-1 Higashi-Ueno, Taito-ku, Tokyo, 110-0015, Japan Telephone: +81 (3) 62843741 Facsimile: +81 (3) 62843657
Contact Person: Naoya Nishimura
Date Prepared: June 30, 2016
Name of Device and Name/Address of Sponsor
PROBEAT-V Proton Beam Therapy System with X-ray Limiting Accessory
Hitachi, Ltd. Healthcare, Hitachi Works 3-1-1 Saiwai-cho, Hitachi-shi, Ibaraki-ken, 317-8511 Japan
Common or Usual Name
Accessory to proton beam therapy system
Classification Name
Medical Charged-Particle Radiation Therapy System, 21 C.F.R. § 892.5050, Product Code LHN
Predicate Devices
PROBEAT-V (K152592)
Intended Use / Indications for Use
The PROBEAT-V with X-ray Limiting Accessory is a medical device designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation.
Technological Characteristics
The PROBEAT-V with X-ray Limiting Accessory is a proton beam irradiation system, which provides a therapeutic proton beam for clinical treatment. It is designed to deliver a proton
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beam with the prescribed dose, dose distribution and directed to the prescribed patient treatment site. The equipment to perform the above work is composed of two main components: (1) a beam delivery system whose primary responsibility is to ensure that the desired prescription parameters are properly delivered and (2) equipment necessary to generate the proton beam and direct it to the beam delivery system for patient treatment.
The X-ray Beam Limiting accessory for use in conjunction with the cleared PROBEAT-V system is designed to limit the patient's X-ray exposure during for patient positioning with the Cone Beam CT (CBCT). The device has 4 motorized leaves which are controlled by the PROBEAT-V imaging software to position the leaves in order to limit the patient's radiation exposure during patient positioning.
Performance Data
Testing was performed to evaluate that the integration of the X-ray Beam Limiting Device with the previously cleared PROBEAT-V does not impact the performance of the system. This testing evaluated slice pitch accuracy, spatial accuracy, spatial resolution, and isocenter accuracy as well as testing with the proton beam therapy positioning system. Electrical safety was evaluated and electromagnetic compatibility testing was performed with the integrated system. In all cases, the device performed as intended and met all pre-specified success criteria.
Substantial Equivalence
The PROBEAT-V with integrated X-ray beam limiting device accessory for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation is substantially equivalent to the cleared PROBEAT-V system. Both the current and cleared devices have the exact same intended use and substantially similar indications for use and technological characteristics. The addition of the X-ray beam limiting accessory to the system does not alter the intended therapeutic effect of the device system, and does not raise new or different questions of safety or efficacy. The addition of this accessory simply allows for minimizing radiation exposure during image acquisition and patient positioning. Thus, the PROBEAT-V Proton Beam Therapy System with X-ray Limiting Accessory is substantially equivalent to its predicate.